Kornimate/medical-research-clean huggingface dataset:
expanded access program of surufatinib

Conditions: Neuroendocrine Tumors

Summary: this treatment protocol is intended to provide early access of surufatinib to patients with locally advanced or metastatic nets for whom, in the opinion of their treating physician, other treatment options or surufatinib clinical trials in this indication are unsuitable. this eap is currently available in the us only.

prior to any assessments, all subjects must provide a signed icf. prior to inclusion in the program, the patients must undergo all appropriate screening procedures to check for eligibility. once eligibility is confirmed, patients will receive treatment with surufatinib 300mg, orally (po), daily (qd). all patients will undergo continuous monitoring for safety until the end of treatment. there is no pre-defined duration of treatment for each patient. patients will be treated until progressive disease (as defined by treating physician), unacceptable toxicity, death, withdrawal from program, the treatment becomes commercially available, or halting of product development. a follow-up clinic visit is recommended for all patients approximately 30 days after last dose of treatment to complete the final safety assessments, as applicable.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically documented, well differentiated, locally advanced or metastatic nets 2. the patient or parent/legal guardian (as appropriate) is willing and able to provide informed consent, and where required, the patient is willing to provide assent 3. ≥12 years of age 4. in the opinion of the patient's treating physician, other treatment options or clinical trials in this indication are unsuitable 5. patient has adequate bone marrow and organ function 6. urine dipstick ≤1+ for proteinuria or ≤30 mg/dl in urinalysis, 7. ecog ≤2 for adult patients (≥18 years of age), karnofsky ≥60 for patients \>16 and \<18 years of age, and lansky ≥60 for pediatric patients ≤16 years of age 8. for female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and partner) to use a highly effective form(s) of contraception exclusion criteria: 1. uncontrollable hypertension, as defined by local institution 2. gastrointestinal disease or condition that the physician suspects may affect drug absorption 3. history or presence of a serious hemorrhage 4. clinically significant cardiovascular disease 5. brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy 6. high risk of bleeding at screening due to tumor invasion 7. arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing or thromboembolic events (including stroke and/or transient ischemic attack) within 6 months prior to first dosing 8. received treatment with anticancer therapy, including investigational therapy, within 7 days or 5 half-lives (whichever is longer) 9. received prior treatment with surufatinib 10. inability to take medication orally 11. any other clinically significant comorbidities that, in the judgment of the treating physician, could predispose the patient to safety risks
rsa - actis hip stem

Conditions: Hip Osteoarthritis

Summary: the principal objective of this study is to compare mean 2-year subsidence of the actis femoral stem using model-based rsa against published migration patterns for hip stems of a similar design. secondary objectives include comparison of migration per surgical approach, quantifying changes in functional and health status of subjects following surgery, and assess occurrences of complications and adverse events.

this is a multi-centre, sequential enrollment trial of patients undergoing primary total hip arthroplasty. patients will be recruited at three canadian centres to receive the actis femoral hip stem via 3 different surgical approaches. model-based rsa will identify migration of the implant with respect to the femoral bone during the first 2 post-operative years. patient health and functional outcomes will be recorded at pre- and post-operative intervals to quantify improvement as a result of the surgery and trajectory of recovery. adverse events and clinical complications in each study group will be captured and compared. select surgical, hospital and rehabilitation data will be collected to measure health economic outcomes relating to the surgery.

Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty * aged 21 years or older * patients willing and able to comply with follow-up requirements and self-evaluations * ability to give informed consent * body mass index ≤45 kg/m2 exclusion criteria * active or prior infection * medical condition precluding major surgery * medical condition with less than 2 years life expectancy * overhanging pannus (for anterior approach cohort only) * prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal) * skin condition on the area of incision * multi-level lumbar spine fusion * ankylosing spondylolithesis * shortening osteotomy through the femur
effect of endoscopic gastric balloon insertion on obstructive sleep apnea in patients with morbid obesity

Conditions: Morbid Obesity; Obstructive Sleep Apnea

Summary: to investigate the effect of weight loss by gastric balloon insertion on parameters of obstructive sleep apnea.

most of the patients with obstructive sleep apnea (osa) are obese. it has been noted that significant weight loss could improve the severity of sleep apnea. significant weight loss is difficult to achieve especially in morbidly obese patients. endoscopic gastric balloon insertion is minimally invasive procedure is employed by surgeon for weight reduction for morbidly obese patients. this study would assess the parameters of sleep which could be affected by weight reduction. if results are positive, this procedure might be considered as treatment for obstructive sleep apnea in morbidly obese patients. patient population would be selected from patients who would undergo gastric balloon insertion in the surgical department. there would be no sex or age limit. patient recruited would have bmi \> 35. consent would be signed for sleep studies. baseline sleep study, lung function, epworth sleepiness scale (ess) and quality of life would be assessed in patients who have symptoms suggestive of osa. if a patient is confirmed to have osa, a continuous positive airway pressure (cpap) titration would be offered if the patient is willing to try cpap. otherwise patients would be discharged home and wait for balloon insertion. the same assessment would be repeated 3 months and 6 months after the surgical procedure. all sleep studies would be done as in-patient. leptin and ghrelin are hormones control satiety, which are also related to the degree of obesity. blood for plasma leptin and ghrelin would be taken before and 6 months after gastric balloon insertion to assess the relationship of weight reduction by reducing appetite and plasma level of the hormones

Eligibility criteria:
inclusion criteria: * morbidly obese patients with bmi \> 30 * confirmed obstructive sleep apnea with rdi \> 10/hr * able to sign consent exclusion criteria: * patients undergoing weight reduction surgery * sleep apnea other than obstructive sleep apnea * untreated endocrine disorder * patient refusal
effect of virtual reality-based relaxation exercise on postoperative pain and kinesiophobia after total knee replacement

Conditions: Randomized Controlled Trial

Summary: the aim of this study is to evaluate the effect of virtual reality-based relaxation exercise on pain and kinesiophobia in patients after total knee arthroplasty.

virtual reality application, which is a non-pharmacological application; it is a three-dimensional simulation model that gives individuals the feeling of reality and allows mutual communication with a dynamic environment created by computers, and studies determining the effects of the application are increasing day by day. virtual reality-based rehabilitation is a promising approach to achieve recovery in many cases, optimize functional outcomes, and increase the clinical and social benefits of surgery . as a result, pain and fear of movement may negatively affect early functional results in patients undergoing total knee arthroplasty. explaining how to change patients' fears, encouraging them to adopt positive attitudes and increasing their physical strength has an important place in determining the effectiveness of virtual reality application.

Eligibility criteria:
inclusion criteria: * the research included people between the ages of 40-75, * volunteering to participate in the research, * being able to understand and speak turkish, * being able to understand the verbal, written and video explanations given, * having no problems communicating cognitively, affectively and verbally, * not having any obstacle to using virtual reality glasses, * patients who underwent unilateral tka surgery, * using the sph device at the same degree for three postoperative days after the ffp operation. * having the surgeon's permission exclusion criteria: * patients who will undergo revision tdp surgery, * those who have a neurological disease that causes functional disability, * those with a diagnosed psychiatric disorder, * refusing to take the sph device after the operation or taking it to a different degree, * those who have a condition that prevents them from wearing virtual glasses for any reason, * these are patients after the ffp operation and outside the third postoperative day.

Keywords: pain kinesiophobia virtual reality glasses
the effect of periodontal treatment on stress and pregnancy relationship

Conditions: Pregnancy Gingivitis

Summary: there is a relationship between stress and pregnancy gingivitis. this relationship may be double-sided.

the aim of this clinical study was to determine the effect of non-surgical mechanical periodontal treatment on sex steroid and stress markers at pregnancy gingivitis. a total of 84 subjects; 22 pregnant women with gingivitis (group 1) and 25 pregnant women with periodontal healthy (pregnant group), group 2), 22 non-pregnant women with gingivitis (group 3) and 15 non-pregnant women with periodontal healthy (non-pregnant group), group 4) participated in this study. clinically, plaque index, gingival index, and probing pocket depth were measured at baseline and after therapy.

Eligibility criteria:
inclusion criteria: * being between the ages of 24-50 * being pregnant for 23-30 weeks (for pregnant individuals) * not smoking. exclusion criteria: * using antimicrobial or anti-inflammatory therapy within the previous 3 months, * having systemic disease, * having periodontitis, * having deep caries lesions, and remnant roots and * having lactation

Keywords: stress
obesity, oral contraception, and ovarian suppression

Conditions: Ovarian Suppression

Summary: this study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used ocs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during oc use.

there is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. this gap may be due to incorrect use or to decreased oral contraceptive (oc) effectiveness in population subgroups. recent reports suggest greater oc failure among heavier women, particularly those using the lowest doses. the prevalence of obesity in the us population has recently increased to about 23% in women aged 20-29, peak years for oc use. oc physiology and effectiveness have not been evaluated in obese women.

Eligibility criteria:
inclusion criteria: * aged 18-35 * body mass index (bmi) 19-24.9 or 30-39.9 kg/m\^2 * willing to take birth control pills for 3-4 months * recent spontaneous pregnancy or cyclic menses exclusion criteria: * contraindications to hormonal contraceptives * oophorectomy/polycystic ovary syndrome (pcos) * taken oral contraceptives to regulate menses recently * weight reduction surgery * used depo-provera within the last 12 months * pregnant or currently breastfeeding * desiring pregnancy within the next 4 months * unable to make study visit commitment * previous participation in this study

Keywords: ovarian suppression oral contraceptives obese and normal bmi
evaluation of walking after repetitive transcranial magnetic stimulation (rtms) inhibitory 1hz in vascular hemiplegia

Conditions: Hemiplegia

Summary: recovery of neurological deficits after stroke results from a reorganization of cortical activities, possibly through brain plasticity. repetitive transcranial magnetic stimulation (rtms-magpror30) produces changes in cortical excitability, generates phenomena of neuroplasticity. its use to improve function after stroke, particularly of the upper limb, was validated. the investigators propose to evaluate in a prospective pilot against placebo, the benefit of rtms at low frequency (1hz) on the unaffected hemisphere in the short and medium term, especially on walking function and spasticity in patients with sequelae of cerebral infarction in the mca territory with gait disturbance and motor weakness of the upper limb.


Eligibility criteria:
inclusion criteria: * age 18-80 years of two sexes * cerebral infarction older than 12 months * nih score \> 4 * patient able to walk with or without technical assistance, rankin score greater than or equal to 3 * no changes can interfere with treatment of spasticity in the 3 months preceding the study (benzodiazepines, baclofen, dantrolene, botulinum toxin ...) * no history of generalized epilepsy unbalanced * free and informed consent signed by the patient * mri with ancient anatomical sequence confirming the accident sylvian exclusion criteria: * stroke with motor sequelae of cerebral infarction prior to qualifying * alteration of the course prior to stroke * generalized epilepsy unbalanced * arrhythmias untreated * injection of botulinum toxin in the previous 4 months of randomization and 2 months after randomization * severe aphasia or cognitive impairment that interferes with the understanding of the tasks * presence of ferromagnetic material intracranial * pacemaker
use of cooled radiofrequency for the treatment of hip pain associated with oa of the hip compared to intra-articular steroid injections

Conditions: Osteo Arthritis of Hip

Summary: this will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled rfa for the treatment of oa hip pain and function in subjects treated with cooled rfa compared with standard of care intra-articular steroid injections


Eligibility criteria:
inclusion criteria: * subjects presenting with radiographic evidence of hip oa and demonstrating hip pain for at least 30 days will be targeted. radiographic evidence of hip oa is defined as kellegran-lawrence grade 2-4 * not an operative candidate as per ri joint replacement surgeon or * subjects who do not desire joint replacement surgery after consultation with ri joint replacement surgeon * male or non-pregnant female older than 18 years of age * willing and able to sign the irb-approved informed consent document. exclusion criteria: * any steroid injection in hip within 90 days * local infection at injection site or active systemic infection * anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and rfa given proximity to major artery. (no anticoagulation contraindications for joint injection) * aicd with inability to utilize magnet for rfa per treating cardiologist * body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment * allergy or severe renal impairment precluding iodionated contrast or magnavist injection despite standard premedication protocol
ultra-proactive therapeutic drug monitoring in inflammatory bowel disease

Conditions: Crohn Disease; Ulcerative Colitis

Summary: this is a comparative pragmatic trial in patients with uc and cd on maintenance treatment with ifx. all ibd patients from cohort a with maintenance ifx treatment at a referral ibd clinic are prospectively included between june and august 2018. an ultra-proactive ifx tdm algorithm is applied as follows. all patients have an elisa tl measurement at baseline, of which the result determined the follow-up pathway: (a) tl between 3-7μg/ml: continuation at same dose and interval; (b) tl \>7μg/ml: interval prolongation allowed; (c) tl \<3μg/ml: interval shortening with minimum 2 weeks, with the next ifx tl measured using a poct. (i) if the poct showed an ifx tl \<3μg/ml, dose was optimized ad hoc using a linear dosing formula (dosen = (tl target \* dose n-1) / tl measured), followed by a new poct test at next visit with the same interval. (ii) if the poct showed an ifx tl ≥3µg/ml, no additional dose was given and routine tl testing with elisa was retaken at next visit. at every visit this algorithm was reapplied to all patients. the patients from cohort a will be compared with the patients from cohort b. the patients in cohort b receive maintenance ifx treatment at a referral ibd clinic during the same period. dose adjustment are done based on standard of care reactive tdm of ifx and clinical symptoms. data will be collected retrospectively to avoid treatment optimization bias.


Eligibility criteria:
inclusion criteria: * all adult ibd patients treated for at least 14 weeks with infliximab were included exclusion criteria: * induction treatment with infliximab (\<14 weeks) * treatment with other biological for ibd

Keywords: therapeutic drug monitoring inflammatory bowel disease point of care testing infliximab
intranasal breast milk therapy in hie

Conditions: Hypoxic-Ischaemic Encephalopathy; Neonatal Encephalopathy; Perinatal Asphyxia; Neonatal Hypoxic Ischemic Encephalopathy

Summary: this is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.

perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (hie) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in hie neonates. improving neurodevelopmental outcomes of newborns with hie has been an intense area of research over the past decade. breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. in preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated. in this open-label prospective randomized controlled single-center interventional study, the objective is to administer fresh, own-mother's breast milk intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days. the primary objective is to compare neurodevelopmental outcomes between the control group and the intervention group receiving intranasal breast milk treatment. the secondary objective is to compare the progression of enteral feeding and the duration of exclusive breastfeeding between the intervention and the control group.

Eligibility criteria:
inclusion criteria: * moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia ≥ 35. gestational week \< 48 hours of life * hypothermia treatment for 72 hours * parental consent form exclusion criteria: * congenital malformation * concurrent cerebral lesions * ecmo therapy * contraindication of lactation * mother unable or unwilling to provide fresh breast milk * postpartum asphyxia

Keywords: hie intranasal breast milk perinatal asphyxia brain breast milk stem cells hypoxic-ischemic encephalopathy
validation of surrogate measures in irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: visceral and somatic hypersensitivity as evidence of central sensory sensitization occur in the majority of irritable bowel syndrome (ibs) patients. we recently demonstrated abnormal endogenous pain modulation as a cause of the sensitization in ibs and identified the underlying dysfunctional neuromatrix using functional mr-imaging (fmri). endogenous pain mechanisms regulate, fine-tune and integrate sensory and homeostatic, including neuroendocrine, immune and autonomic nervous system processes. specific measures of sensitization and endogenous pain modulation correlate with clinical measures of somatic and neuropathic pain, suggesting usefulness as surrogate markers for clinical pain outcomes. validation of experimental measures as surrogate markers in ibs would provide a considerable advance in pathophysiological and therapeutic research in this pharmacoeconomically burdensome disease.


Eligibility criteria:
inclusion criteria: ibs patients: * one hundred fifty male and female ibs patients (rome iii criteria), aged 18 to 70 years, recruited from primary and secondary care via advertisements and referral networks. * minimum ibs symptom rating of 75 in ibs severity scoring system (ibs-sss) in last two weeks. * ibs discomfort or pain must have been patient's most prominent symptom. * a minimum of 40 patients each ibs-constipated (ibs-c) and ibs-diarrhoeic (ibs-d) (rome iii) to be included. * patients must have been off all ibs and analgesic medication and any drugs potentially influencing sensory function for at least two weeks before study start. healthy controls: * fifteen healthy controls aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months. exclusion criteria: exclusion criteria for both ibs patients and healthy controls: * organic gastrointestinal or other significant systemic disease, including cardiovascular, psychiatric, neurological and endocrine diseases, as judged by investigator * chronic or acute pain, except related to other functional syndromes (functional dyspepsia, chronic pelvic pain, fibromyalgia, migrane) * bowel resections (except appendectomy) * multiple abdominal operations, excluding hysterectomy * history of brain disease or brain surgery * ongoing treatment with any anticoagulants, antidiabetics, antimigraine drugs, antispasmodics, analgesics, psychoactive agents including antidepressants, zelmac®, tcm or acupuncture for ibs and any drugs affecting nociception as judged by investigator within last 14 days * treatment with any investigational drug during the preceding 30 days * pregnancy or lactation. * claustrophobia * metal implants in body (fmri exclusion criterion) * no written informed consent obtained from subject